EU Council: New Rules to Prevent Medical Device Shortages

The EU Council has adopted new rules to prevent medical device shortages and ease the transition to greater transparency and access to information. Below is how the regulation amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs): 

• • Further extends the transition period for certain IVDs. 
  • Enables a gradual roll-out of EUDAMED, the new electronic database. 
  • Requires manufacturers to flag up potential shortages of critical medical devices and IVDs. 

What are the key changes? 

• • The amendment extends the transition deadline under certain conditions to prevent critical IVD shortages without compromising safety. 
  • The new regulation allows a gradual roll-out of the European database on medical devices (EUDAMED). Manufacturers must provide information to existing EUDAMED modules without waiting for the completion of all modules. This mandatory registration will begin in late 2025. 
  • The revision mandates manufacturers to provide advance notice of any supply interruptions for certain critical medical devices or IVDs to relevant authorities, health institutions, healthcare professionals, and economic operators receiving the devices. 

Next steps 

The regulation adopted yesterday will take effect after its publication in the EU’s Official Journal. You can read the full press release here. 

______________________________________________

If you have questions about the new rules adopted by the EU Council, don’t hesitate to contact us so we can help you. 

Learn how MedEnvoy can assist you:

• • EU Authorized Representative
  • EU Regulatory Importer
  • RA Consulting
  • QA Consulting